EyePoint Pharmaceuticals(EYPT) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments EyePoint Pharmaceuticals reported Q2 2025 results, emphasizing rapid DURAVYU Phase 3 enrollment, manufacturing, and a strong cash runway into 2027 Q2 2025 Highlights and Corporate Developments EyePoint Pharmaceuticals announced its second quarter 2025 financial results and highlighted significant corporate advancements, including rapid Phase 3 enrollment for DURAVYU, initiation of commercial manufacturing, and a strong cash position into 2027 - Completed enrollment in both pivotal Phase 3 trials, LUGANO and LUCIA, for DURAVYU in wet AMD in record time, with over 800 patients enrolled and randomized[3][5][6] - Topline LUGANO data is anticipated in mid-2026, with LUCIA data to closely follow in the second half of 2026[3][6] - Initiated DURAVYU registration batches at the Northbridge, MA commercial manufacturing facility, which is now operational and built to meet FDA and EMA standards[2][3][7] - Cash, cash equivalents, and marketable securities totaled $256 million as of June 30, 2025, providing a cash runway into 2027, extending beyond topline data for both Phase 3 wet AMD trials[2][11][12] Research & Development Updates EyePoint completed Phase 3 enrollment for DURAVYU in wet AMD and advanced its DME program with positive Phase 2 results and FDA discussions DURAVYU™ Wet AMD Program EyePoint completed Phase 3 enrollment for DURAVYU in wet AMD, with the LUGANO and LUCIA trials demonstrating unprecedented recruitment rates, consistent interim safety data, and EMA approval of Phase 3 protocols - LUGANO and LUCIA trials each rapidly enrolled in seven months, exceeding observed recruitment rates of comparable historical and ongoing wet AMD clinical trials, underscoring strong physician and patient interest[5][6] - The oversubscribed LUGANO trial randomized 432 patients in the U.S. with topline data anticipated in mid-2026. LUCIA randomized over 400 patients in the U.S. and ex-U.S. sites, with topline data anticipated in the second half of 2026[6] - Interim masked safety data for LUGANO and LUCIA is consistent with previous DURAVYU clinical trials, and an independent Data Safety Monitoring Committee (DSMC) recommended continuation of the program as planned[10] - Received approval of the Phase 3 protocols for the LUGANO and LUCIA trials by the European Medicines Agency (EMA)[10] DURAVYU™ DME Program The company completed a positive End-of-Phase 2 meeting with the FDA for DURAVYU in Diabetic Macular Edema (DME) and presented promising 24-week topline results from the Phase 2 VERONA study - Completed a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss pivotal Phase 3 clinical trial plans for DURAVYU in DME, with details on the DME pivotal plan to be shared in the second half of 2025[10] - Presented 24-week topline results from the Phase 2 VERONA study in DME at the Retina World Congress, highlighting DURAVYU's potential to transform the treatment landscape with its best-in-class safety and efficacy profile[10] - Accepted to present the Phase 2 VERONA 24-week end-of-study results in DME at the Retina Society Annual Meeting in September, underscoring broad treatment potential[10] Manufacturing and Operations EyePoint initiated commercial manufacturing for DURAVYU at its Northbridge facility, built to FDA and EMA standards to meet anticipated demand DURAVYU™ Commercial Manufacturing EyePoint has initiated DURAVYU registration batches at its state-of-the-art, 41,000-square-foot commercial manufacturing facility in Northbridge, Massachusetts, built to meet FDA and EMA standards and support significant anticipated demand - Initiated DURAVYU registration batches in support of a potential NDA filing at EyePoint's commercial manufacturing facility in Northbridge, Massachusetts[7] - The 41,000-square-foot facility was built to meet both FDA and EMA standards and will have capacity to support the anticipated significant demand for DURAVYU, if approved[7] Financial Performance EyePoint reported a Q2 2025 net revenue of $5.3 million and a net loss of $59.4 million, projecting a cash runway into 2027 Second Quarter 2025 Financial Results EyePoint reported a total net revenue of $5.3 million for Q2 2025, a decrease from $9.5 million in Q2 2024, primarily due to lower recognition of deferred revenue, with operating expenses significantly increasing to $67.6 million, resulting in a net loss of $59.4 million, or ($0.85) per share Q2 Financial Performance (in thousands) | Financial Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :----------------- | :------------------------------- | :------------------------------- | :----------- | | Total Net Revenue | $5,333 | $9,477 | -43.8% | | License & Royalties| $5,333 | $8,409 | -36.6% | | Operating Expenses | $67,560 | $44,023 | +53.5% | | Net Loss | $(59,426) | $(30,826) | +92.8% | | Net Loss per Share | $(0.85) | $(0.58) | +46.6% | - The decrease in license and royalties revenue was primarily driven by lower recognition of deferred revenue related to the Company's 2023 agreement for the license of YUTIQ® product rights[9] - The increase in operating expenses was primarily driven by an increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD[10][11] Cash, Cash Equivalents, and Marketable Securities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $71,143 | $99,704 | | Marketable securities | $184,590 | $271,209 | | Total Cash, Cash Equivalents, and Marketable Securities | $255,733 | $370,913 | Financial Outlook EyePoint projects that its current cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2027, extending beyond the anticipated topline Phase 3 data for DURAVYU in wet AMD - EyePoint expects its cash, cash equivalents, and marketable securities as of June 30, 2025, totaling $256 million, will enable the Company to fund operations into 2027, beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026[2][11][12] Company Information EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, with DURAVYU™ as its lead candidate About EyePoint Pharmaceuticals EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics for serious retinal diseases, with DURAVYU™ as its lead investigational sustained delivery treatment - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases[14] - DURAVYU™ is an innovative investigational sustained delivery treatment for VEGF-mediated retinal diseases, combining vorolanib (a selective and patent-protected tyrosine kinase inhibitor) in next-generation bioerodible Durasert E™ technology[14] - DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) with topline data anticipated in 2026, and has completed a positive Phase 2 clinical trial in diabetic macular edema (DME) with Phase 3 pivotal planning underway[14] - Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan[16] Forward-Looking Statements This section provides a standard disclosure regarding forward-looking statements, outlining the company's expectations for clinical development, regulatory approvals, market positioning, and financial outlook, while detailing various risks and uncertainties that could cause actual results to differ materially from these projections Consolidated Financial Statements This section presents EyePoint's consolidated balance sheets and statements of operations, detailing financial position and performance for Q2 2025 Consolidated Balance Sheets The consolidated balance sheets present EyePoint's financial position as of June 30, 2025, and December 31, 2024, showing a decrease in total assets and stockholders' equity over the six-month period Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Assets | | | | Cash and cash equivalents | $71,143 | $99,704 | | Marketable securities | $184,590 | $271,209 | | Total current assets | $265,251 | $383,306 | | Total assets | $301,147 | $418,465 | | Liabilities | | | | Total current liabilities | $33,175 | $49,048 | | Deferred revenue | $0 | $17,784 | | Total liabilities | $55,138 | $81,964 | | Stockholders' Equity | | | | Total stockholders' equity | $246,009 | $336,501 | Consolidated Statements of Operations The consolidated statements of operations detail EyePoint's revenues and expenses for the three and six months ended June 30, 2025, and 2024, indicating a significant increase in net loss primarily driven by higher research and development expenditures Consolidated Statements of Operations Highlights (in thousands) | Income Statement Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenues | $5,333 | $9,477 | $29,786 | $21,161 | | Research and development | $55,498 | $29,822 | $114,072 | $60,011 | | Total operating expenses | $67,560 | $44,023 | $140,850 | $89,028 | | Loss from operations | $(62,227) | $(34,546) | $(111,064) | $(67,867) | | Net loss | $(59,426) | $(30,826) | $(104,621) | $(60,110) | | Net loss per common share | $(0.85) | $(0.58) | $(1.50) | $(1.13) |